Manufacturing Engineer

The Manufacturing Engineer will be responsible for the support and troubleshooting of manufacturing floor, processes and assembly with direct participation in managing CIs, quality issues investigations NMRs in order to ensure full compliance to FDA QSR (21 CFR 820), and applicable ISO 13485 requirements. Perform work in adherence to the CMD Quality Management System (QMS), including development and maintenance of documentation.

Specific duties and responsibilities:

Support the troubleshooting of equipment and manufacturing processes

Develop bills of materials and assembly methods, update work instructions and provide any needed training to technicians and assemblers related to processes and equipment

Work in a cross-functional environment partnering with RD and Quality departments in order to deliver product that meets customer requirements, on time delivery and quoted price.

Create tooling and fixtures to improve the manufacturing processes and ease the operators job in the assembly area

Support and execute CI projects in order to reduce the cost and improve yields in the production area.

Working knowledge of manufacturing processes related to catheter manufacturing